The following data is part of a premarket notification filed by Mri Devices Corp. with the FDA for Breast Immobiization And Biopsy Device Mr-biopsy 160.
| Device ID | K010570 |
| 510k Number | K010570 |
| Device Name: | BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha, WI 53186 |
| Contact | Thomas Schubert |
| Correspondent | Thomas Schubert MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha, WI 53186 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-26 |
| Decision Date | 2001-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251269205316 | K010570 | 000 |
| 04251269202292 | K010570 | 000 |
| 04251269202278 | K010570 | 000 |
| 04251269202261 | K010570 | 000 |
| 04251269202247 | K010570 | 000 |
| 04251269202230 | K010570 | 000 |
| 04251269202186 | K010570 | 000 |
| 04251269202179 | K010570 | 000 |
| 04251269202155 | K010570 | 000 |
| 04251269202131 | K010570 | 000 |
| 04251269202124 | K010570 | 000 |
| 04251269202100 | K010570 | 000 |
| 04251269201813 | K010570 | 000 |
| 04251269202308 | K010570 | 000 |
| 04251269202315 | K010570 | 000 |
| 04251269202322 | K010570 | 000 |
| 04251269203206 | K010570 | 000 |
| 04251269203190 | K010570 | 000 |
| 04251269203183 | K010570 | 000 |
| 04251269202452 | K010570 | 000 |
| 04251269202445 | K010570 | 000 |
| 04251269202421 | K010570 | 000 |
| 04251269202414 | K010570 | 000 |
| 04251269202407 | K010570 | 000 |
| 04251269202384 | K010570 | 000 |
| 04251269202377 | K010570 | 000 |
| 04251269202353 | K010570 | 000 |
| 04251269202339 | K010570 | 000 |
| 04251269201769 | K010570 | 000 |